Medtronic Launches OmniaSecure™, the World’s Smallest Defibrillation Lead, in the U.S.

Medtronic Announces Launch in the U.S.Thinnest Defibrillation Lead---OmniaSecure，OmniaSecureWith a diameter of only 4.7Fr (1.6 millimeters), approximately the thickness of a graphite core in a wooden pencil.

OmniaSecureWas approved for marketing by the FDA in May of last year.OmniaSecureConnected to an implantable defibrillator for the treatment of potentially life-threatening ventricular tachyarrhythmias, ventricular fibrillation (VT/VF), and bradyarrhythmias. As the world's smallest defibrillation lead (4.7 French, approximately 1.6 millimeters), the OmniaSecure lead represents a significant innovation in the field of electrophysiology and is suitable forRight Ventricular Pacing for Adult and Adolescent Patients Aged 12 Years and Above, including patients with smaller anatomical structures.

Executive Evaluation

"We are proud to bring this technology to patients in the United States. In the U.S., implantable cardioverter-defibrillators (ICDs) are crucial for preventing sudden cardiac death. The new thin-diameter OmniaSecure defibrillation lead is designed for long-term reliability and provides dependable therapy when used with transvenous ICDs or cardiac resynchronization therapy defibrillators (CRT-Ds). We look forward to physicians utilizing this innovative technology to continue delivering exceptional care to patients."

---Trevor Cook Vice President and General Manager of Medtronic's Cardiac Rhythm Management Business Defibrillation Solutions

CurrentlyOmniaSecure has already beenSeveral hospitals in the United States have carried out the first implant surgeries post-market launch. Meanwhile, Medtronic alsoPublishLEADR Pivotal TrialFinal Results. The study confirmed that OmniaSecure has excellent defibrillation efficacy, safety, and reliability.

Specific Research Data (Three Years Post-Surgery)

• OmniaSecureHigh defibrillation success rate demonstrated at implantation and during dynamic follow-up of up to three years.

• Low risk of complications, with 96.5% of patients not experiencing major complications related to OmniaSecure.

• OmniaSecure demonstrated reliable performance with a high ATP success rate, appropriate shock therapy delivered to 22.3% of patients with indications, and stable electrical performance.

• OmniaSecureDemonstrates high reliability, with a zero-fracture rate consistent with the predicted 10-year 98.2% reliability model.

• Minimum Diameter Defibrillation Lead

• High Implantation Success Rate

• Highly Reliable Structural Design

• Multi-functional Treatment Assurance

Integrated bipolar single-coil design, supports DF4 interface connection

Synchronously achieve pacing, sensing, cardioversion, and defibrillation functions

MRI SureScan Technology is Compatible with MRI Scans

Offering a variety of catheter options to meet the needs of different anatomical structures

Medtronic

Medtronic is a global leader in medical technology, with the mission of "alleviating pain, restoring health, and extending life." Through innovative technologies, it transforms the lives of millions of people worldwide each year. Its products cover 70 disease areas, including cardiac devices, surgical robots, and insulin pumps, with more than 95,000 employees dedicated to advancing the future of human health through insight-driven healthcare solutions.